Effects of Maze Activities in Down's Syndrome

NCT ID: NCT06234644

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2024-02-10

Brief Summary

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Down's Syndrome is due to the chromosomal disorder in 47 chromosomes instead of 46, socalled as Trisomy 21. The syndrome has several clinical symptoms including Cardiovascular,neurological, orthopedic, hormonal, cognitive and visual perceptual impairments. These childrenhave Developmental Delay. Children have hypermobility of joints, hypotonicity or ligamentous laxity, light to moderate obesity, due to underdeveloped respiratory and cardiovascular systemandshortstaturewhichleadtodecreaseinfunctionalambulation.Due to the low level of physical fitness, theseindividuals shows limitation in performing the functional tasks of daily living. The fundamental motor skill is Walking that facilitates the child to interact with the environment and helps indeveloping, social, motor and cognitive skills. Due to their delayed milestones and due to the irintellectual disability, environmental exposure is limited which hampers this fundamental skill.Hence it is necessary to asses the functional ambulation in these children.

This is a Randomized Controlled Trial that will be conducted in Rising Sun Institute Of Special Children. 26 participants will be allocated randomly into 2 groups Group A will receive the conventional interventions of Down's Syndrome but the group B will receive the mobility training with Standardized Walking Obstacle Course (SWOC). Tool used for this research will be a Standardized Walking Obstacle Course (SWOC) (that is used to measure stability and speed during gait in terms of time, number of steps, number of stumbles and number of steps off the path for each participant) and Timed up and go test (Valid for the functional mobility assessment of the children with DS). The data will be analyzed by SPSS version 21

Detailed Description

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This study will be a randomized control trail used to compare the Effects of Maze Activities on Mobility in Children With Down's Syndrome. Subjects with Down's syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique. Assessment will be done by using time up and go test and Standardized Walking Obstacle Course (SWOC). Subjects in group A will receive the conventional intervention of gait training and Group B will receive the training on Standardized walking obstacle course.

Conditions

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Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

The Group A (experimental group) will receive the treatment with Standardized walking obstacle course (SWOC).

Group Type ACTIVE_COMPARATOR

Standardized Walking Obstacle Course (SWOC)

Intervention Type OTHER

The Standardized Walking Obstacle Course (SWOC) is a test that allows interaction of a child with environmental demands and obstructions while examining differences in functional ambulation performances. The Group A (experimental group) will receive the treatment with Standardized walking obstacle course (SWOC), the group of 13 participants will receive the treatment. This group will receive therapy session for 45 min, thrice a week for 6 weeks, total sessions will be 18. 45 minutes session time will be divided into 15 min warm up period, 25 minutes of SWOC training and 5 minutes of cool down period.

Group B

The Group B (Control group) will receive the treatment with conventional Gait training.

Group Type ACTIVE_COMPARATOR

Conventional Gait Training

Intervention Type OTHER

Conventional gait training protocol including walking on a treadmill, parallel bar walk, seated marching. The Group B (Control group) will receive the treatment with conventional Gait training, the group of 13 participants will receive the treatment. This group will receive therapy session for 45 min, thrice a week for 6 weeks, total sessions will be 18. 45 minutes session time will be divided into 15 min warm up period, 25 minutes of Conventional gait training and 5 minutes of cool down period.

Interventions

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Standardized Walking Obstacle Course (SWOC)

The Standardized Walking Obstacle Course (SWOC) is a test that allows interaction of a child with environmental demands and obstructions while examining differences in functional ambulation performances. The Group A (experimental group) will receive the treatment with Standardized walking obstacle course (SWOC), the group of 13 participants will receive the treatment. This group will receive therapy session for 45 min, thrice a week for 6 weeks, total sessions will be 18. 45 minutes session time will be divided into 15 min warm up period, 25 minutes of SWOC training and 5 minutes of cool down period.

Intervention Type OTHER

Conventional Gait Training

Conventional gait training protocol including walking on a treadmill, parallel bar walk, seated marching. The Group B (Control group) will receive the treatment with conventional Gait training, the group of 13 participants will receive the treatment. This group will receive therapy session for 45 min, thrice a week for 6 weeks, total sessions will be 18. 45 minutes session time will be divided into 15 min warm up period, 25 minutes of Conventional gait training and 5 minutes of cool down period.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* •Age 6 to 12 years of downs's syndrome children

* Ambulatory Child who can walk without any assistive device(6)
* Should follow commands and can perform 30 sec walk test.(6)

Exclusion Criteria

* •Any congenital Cardiac Anomaly

* Visual and Hearing Deficits
* Any surgical intervention for the last 6 months
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fibha Tariq, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah international university lahore

Locations

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Riphah international university lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Kott KM, Held S, Franjoine MR. Reference data for performances on the standardized walking obstacle course in children developing typically. Gait Posture. 2016 Sep;49:398-401. doi: 10.1016/j.gaitpost.2016.08.001. Epub 2016 Aug 2.

Reference Type BACKGROUND
PMID: 27505143 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/23/0747

Identifier Type: -

Identifier Source: org_study_id

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